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US Food and Drug Administration (FDA) - Establishment Registration

FDA Registered Companies - Updated May 2006

What is Establishment Registration?

Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. This process is known as establishment registration.
FDA Registrations
FDA Registrations
FDA Registrations
FDA Registrations


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Establishment Owner/Operator
SOON MEI DENTAL COMPANY
KOWLOON,  HK.
Manufacturer;  
LIN DE ZHI/EXCELDENT DENTAL TECHNOLOGY CENTER
ZHUHAI,  CH.
SOPER BROTHERS & ASSOCIATES
HOUSTON,  TX,  US.
Manufacturer;  
SOPER BROTHERS & ASSOCIATES
HOUSTON,  TX ,  US.
SOPER'S MOBILITY AIDS, L.L.C.
HAYDEN,  ID,  US.
Initial Importer;  
SOPER'S MOBILITY AIDS, L.L.C.
HAYDEN,  ID ,  US.
SOPHYSA SA
ORSAY, CEDEX,  FR.
Manufacturer;  
SOPHYSA SA
ORSAY, CEDEX,  FR.
SOPHYSA USA
COSTA MESA,  CA,  US.
Initial Importer;  
SOPHYSA SA
ORSAY, CEDEX,  FR.
SOPRO
LA CIOTAT CEDEX,  FR.
Manufacturer;  
SOPRO
LA CIOTAT CEDEX,  FR.
SORB TECHNOLOGY, INC.
OKLAHOMA CITY,  OK,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
RENAL SOLUTIONS, INC.
WARRENDALE,  PA ,  US.
SORBA MEDICAL SYSTEMS, INC.
BROOKFIELD,  WI,  US.
Manufacturer;  
SORBA MEDICAL SYSTEMS, INC.
BROOKFIELD,  WI ,  US.
SORBION GROUP USA
LAKE ELMO,  MN,  US.
Initial Importer;  
SORBION GROUP USA
LAKE ELMO,  MN ,  US.
SORBOTHANE, INC.
KENT,  OH,  US.
Manufacturer;  
SORBOTHANE, INC.
KENT,  OH ,  US.
SOREDEX PALODEX GROUP OY
TUUSULA,  FI.
Manufacturer;   Specification Developer;  
SOREDEX PALODEX GROUP OY
TUUSULA,  FI.
SOREK MEDICAL SYSTEMS, LTD.
YOKNEAM ILLIT,  IS.
Contract Manufacturer;  
ROBIN MEDICAL, INC.
BALTIMORE,  MD ,  US.
SORENSON MEDICAL, INC.
WEST JORDAN,  UT,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SORENSON MEDICAL, INC.
WEST JORDAN,  UT ,  US.
SORIN BIOMEDICA C.R.M., S.R.L.
SALUGGIA VC,  IT.
Contract Manufacturer;  
SORIN BIOMEDICA CRM, S.R.L.
SALUGGIA VC,  IT.
SORIN GROUP DEUTSCHLAND GMBH
MUNCHEN,  GM.
Manufacturer;  
SORIN GROUP DEUTSCHLAND GMBH
MUNCHEN,  GM.
SORIN GROUP ITALIA S.R.L
MIRANDOLA(MO),  IT.
Manufacturer;  
SORIN GROUP ITALIA S.R.L
MIRANDOLA(MO),  IT.
SORING, INCORPORATED
FORT WORTH,  TX,  US.
Initial Importer;  
SORING, INCORPORATED
FORT WORTH,  TX ,  US.
SORNA CORP.
EAGAN,  MN,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SORNA CORP.
EAGAN,  MN ,  US.
SORRENTO BIOCHEMICAL, INC.
SAN DIEGO,  CA,  US.
Contract Manufacturer;   Manufacturer;  
SORRENTO BIOCHEMICAL, INC.
SAN DIEGO,  CA ,  US.
SOS SURGICAL CO.,
GOHADPUR,  PK.
Unregistered Foreign Lister;  
SOS SURGICAL CO.,
GOHADPUR,  PK.
SO-SHE ENTERPRISE CO., LTD.
CHANG HUA CITY,  TW.
Manufacturer;  
SO-SHE ENTERPRISE CO., LTD.
CHANG HUA CITY,  TW.
SOTA MEDICAL
ORCHARD PARK,  NY,  US.
Specification Developer;  
SOTA MEDICAL
ORCHARD PARK,  NY ,  US.
SOTA PRECISION OPTICS, INC.
ORANGE,  CA,  US.
Manufacturer;  
SOTA PRECISION OPTICS, INC.
ORANGE,  CA ,  US.
SOTIRIA MOURKIDOU
OXNARD,  CA,  US.
Specification Developer;  
SOTIRIA MOURKIDOU
OXNARD,  CA ,  US.
SOUND BUSINESS FORMS
SEATTLE,  WA,  US.
Initial Importer;  
SOUND BUSINESS FORMS
SEATTLE,  WA ,  US.
SOUND FORESIGHT LIMITED
BARNSLEY, YORKSHIRE,  UK.
Manufacturer;  
SOUND FORESIGHT LIMITED
NORTH YORKSHIRE,  UK.
SOUND HAN INDUSTRIAL CO., LTD.
TAICHUNG,  TW.
Manufacturer;  
SOUND HAN INDUSTRIAL CO., LTD.
TAICHUNG,  TW.
SOUND ID
PALO ALTO,  CA,  US.
Specification Developer;  
SOUND ID
PALO ALTO,  CA ,  US.
SOUND IMAGING CORP.
ENGLEWOOD,  NJ,  US.
Manufacturer;   Remanufacturer;   Specification Developer;  
SOUND IMAGING CORP.
ENGLEWOOD,  NJ ,  US.
SOUND MEDICAL CORP.
NAN-TOU,  TW.
Foreign Exporter;   Manufacturer;  
SOUND MEDICAL CORP.
NAN-TOU,  TW.
SOUND PARTS, INC.
SARASOTA,  FL,  US.
Manufacturer;  
SOUND PARTS, INC.
SARASOTA,  FL ,  US.
SOUND SURGICAL TECHNOLOGIES LLC.
LOUISVILLE,  CO,  US.
Manufacturer;   Specification Developer;  
SOUND SURGICAL TECHNOLOGIES LLC.
LOUISVILLE,  CO ,  US.
SOUND TECHNIQUES SYSTEMS, LLC
NEWPORT NEWS,  VA,  US.
Manufacturer;   Specification Developer;  
SOUND TECHNIQUES SYSTEMS, LLC
NEWPORT NEWS,  VA ,  US.
SOUND TECHNOLOGY INC.
STATE COLLEGE,  PA,  US.
Contract Manufacturer;  
ANALOGIC CORP.
PEABODY,  MA ,  US.
SOUNDS OF LIFE HEARING CENTER
PORTLAND,  OR,  US.
Manufacturer;  
SOUNDS OF LIFE HEARING CENTER
LAS VEGAS,  NV ,  US.
SOUNDSKIN LLC.
RIVER FOREST,  IL,  US.
Initial Importer;  
SOUNDSKIN LLC.
RIVER FOREST,  IL ,  US.
SOUNDTEC, INC.
OKLAHOMA CITY,  OK,  US.
Manufacturer;  
SOUNDTEC, INC.
OKLAHOMA CITY,  OK ,  US.
SOUNMED, INC.
KATY,  TX,  US.
Initial Importer;  
SOUNMED, INC.
KATY,  TX ,  US.
SOURCE DIRECT INTERNATIONAL
TARPON SPRINGS,  FL,  US.
Initial Importer;  
SOURCE DIRECT INTERNATIONAL
TARPON SPRINGS,  FL ,  US.
SOURCE MARK
NASHVILLE,  TN,  US.
Initial Importer;  
SOURCE MARK
NASHVILLE,  TN ,  US.

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Last Modified: 29 April 2006
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